Using ultrasound to treat alcohol use disorder

Ultrasound Neuromodulation of the Brain for Alcohol Use Disorder

This study is testing if using low-intensity ultrasound can help change brain activity in people with alcohol use disorder.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 25 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of California, San Francisco (Academic / other)
• Locations: 1 site (San Francisco, California)
• Trial ID: NCT06518785 on ClinicalTrials.gov

What this trial studies

This study examines the effects of Low-Intensity Focused Ultrasound (LIFU) on brain activity in individuals with alcohol use disorder. It is a single-center, double-blind, controlled, randomized, complete block, 2-period crossover pilot trial. The research will assess how LIFU engages the ventral striatum by utilizing resting state and task-based functional magnetic resonance imaging (fMRI) to measure brain activity changes in response to the treatment.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older who have a documented diagnosis of alcohol use disorder.

Not a fit: Patients who are pregnant, have significant cognitive impairment, or are currently undergoing other investigational treatments for alcohol use disorder may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a non-invasive treatment option for individuals struggling with alcohol use disorder.

How similar studies have performed: While the use of ultrasound for neuromodulation is a novel approach, similar studies have shown promise in other neurological conditions, indicating potential for success in this area.

Eligibility criteria

Inclusion Criteria:

1. Male or female ≥ 18 years of age.
2. Documentation of an AUD diagnosis per DSM-5 criteria as evidenced by problematic pattern of alcohol use leading to clinically significant impairment or distress, as manifested by at least two of the DSM-5 criteria, occurring within a 12-month period.
3. Be willing to undergo a brain MRI and follow study protocol.

Exclusion Criteria:

1. Pregnant or breastfeeding.
2. Presence of a condition or abnormality that would compromise the safety of the patient or the quality of the data.
3. Non-English speaking.
4. Other investigational AUD treatments.
5. Primary psychosis, Bipolar I, or severe personality disorder.
6. Active suicidality or history of suicide attempt in the past 5 years.
7. Cognitive impairment (MoCA \<24)
8. Significant medical or neurological disease, or life expectancy \<12 mos.
9. Significant brain abnormality on brain imaging.
10. Any MRI exclusion criteria.

Where this trial is running

San Francisco, California

• University of California, San Francisco — San Francisco, California, United States (Recruiting)

Study contacts

• Principal investigator: Khaled Moussawi, MD, PhD — University of California, San Francisco
• Study coordinator: Catherine Borror, BS, CCRP

Conditions Alcohol Use Disorder; Substance Use Disorder; Low-Intensity Focused Ultrasound; Transcranial Focused Ultrasound; Neuromodulation